MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number PM3542

Device Problems Premature Discharge of Battery (1057); Capturing Problem (2891)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

Further information requested, but not received.

Event Description

It was reported.A patient's pacemaker presented with high capture thresholds and premature battery depletion.The device was explanted and replaced in a procedure on (b)(6) 2023.Post-procedure the patient was stable.

Event Description

Related manufacturer reference number: 2017865-2024-00102.It was reported a patient's pacemaker presented with high capture thresholds and premature battery depletion.The left ventricular (lv) lead also had high capture thresholds.The pacemaker and lv lead were explanted and replaced in a procedure on (b)(6) 2023.Post-procedure the patient was stable.

Manufacturer Narrative

Field event of capture problem and premature depletion were not confirmed.As received device was in normal range of operation and no anomalies were noted.Output, pacing and capture functions of the device were tested and found to be normal.Further analysis performed, including electrical, thermal and mechanical testing of the device did not find any anomaly.Assessment of total longevity was performed, and device was found to have appropriate remaining longevity.

• Brand Name: QUADRA ALLURE MP
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18288415
• MDR Text Key: 329993283
• Report Number: 2017865-2023-94237
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: PM3542
• Device Lot Number: P000100602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention